{"id":374168,"date":"2024-10-20T02:37:18","date_gmt":"2024-10-20T02:37:18","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-13485-2016\/"},"modified":"2024-10-26T04:34:56","modified_gmt":"2024-10-26T04:34:56","slug":"aami-13485-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-13485-2016\/","title":{"rendered":"AAMI 13485 2016"},"content":{"rendered":"

This document provides requirements and recommendations to writers of medical devicestandards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology. This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these. In this document, the term “product” includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nBlank Page <\/td>\n<\/tr>\n
8<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
25<\/td>\n1\tScope <\/td>\n<\/tr>\n
29<\/td>\n2\tNormative references <\/td>\n<\/tr>\n
31<\/td>\n3\tTerms and definitions <\/td>\n<\/tr>\n
33<\/td>\n4\tQuality management system <\/td>\n<\/tr>\n
61<\/td>\n5\tManagement responsibility <\/td>\n<\/tr>\n
81<\/td>\n6\tResource management <\/td>\n<\/tr>\n
95<\/td>\n7\tProduct realization <\/td>\n<\/tr>\n
167<\/td>\n8\tMeasurement, analysis and improvement <\/td>\n<\/tr>\n
211<\/td>\nAnnex\u00a0A\u00a0\u2014 Guidance for small organizations <\/td>\n<\/tr>\n
217<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO 13485:2016 Medical Devices-A Practical Guide, Advice from ISO\/TC 210<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2016<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":374171,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-374168","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/374168","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/374171"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374168"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374168"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374168"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}